Trapost OSD 0.00004

INDICATIONS

Travoprost, a prostaglandin analog is a selective FP prostanoid receptor agonist, which is believed to reduce IOP by increasing uveoscleral outflow. Travoprost, an isopropyl ester prodrug is absorbed through the cornea and is hydrolyzed by esterases in the cornea to its biologically active free acid.

PHARMACOLOGY

Travoprost 0.004% ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

DOSAGE & ADMINISTRATION

The recommended dosage is one drop in the affected eye(s) once daily in the evening. Optaprost should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the IOP lowering effect.Pediatric Use: Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long term chronic use.Geriatric Use: No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

INTERACTION

Reduced therapeutic effect with NSAIDs.

SIDE EFFECTS

The most common adverse reaction observed in controlled clinical trials with Travoprost ophthalmic solution 0.004% was ocular hyperemia, which was reported in 30% to 50% of patients. Up to 3% of patients discontinued therapy due to conjunctival hyperemia. Ocular adverse reactions, reported at an incidence of 5% to 10% in these clinical trials, included decreased visual acuity, eye discomfort, foreign body sensation, pain, and pruritus.Ocular adverse reactions, reported at an incidence of 1% to 4% in clinical trials with Travoprost ophthalmic solution 0.004%, included abnormal vision, blepharitis, blurred vision, cataract, conjunctivitis, corneal staining, dry eye, iris discoloration, keratitis, lid margin crusting, ocular inflammation, photophobia, subconjunctival hemorrhage, and tearing. Non ocular adverse reactions, reported at an incidence of 1% to 5% in these clinical studies, were allergy, angina pectoris, anxiety, arthritis, back pain, bradycardia, bronchitis, chest pain, cold/flu syndrome, depression, dyspepsia, gastrointestinal disorder, headache, hypercholesterolemia, hypertension, hypotension, infection, pain, prostate disorder, sinusitis, urinary incontinence, and urinary tract infections.

PREGNANCY & LACTATION

There are no adequate and well-controlled studies in pregnant women to inform a drug-associated risk. There are no data on the effects of Travoprost on the breastfed child or milk production. It is not known if Travoprost is present in human milk following ophthalmic administration.

PRECAUTIONS & WARNINGS

Pigmentation: Travoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris (brownish), periorbital tissue (eyelid), and eyelashes.Eyelash Changes: Travoprost ophthalmic solution may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and number of lashes.Intraocular Inflammation: Travoprost ophthalmic solution should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.Macular Edema: Macular edema, including cystoid macular edema, has been reported during treatment with Travoprost ophthalmic solution. Travoprost ophthalmic solution should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.Use with Contact Lenses: Contact lenses should be removed prior to instillation of Travoprost ophthalmic solution and may be reinserted 15 minutes following its administration.

THERAPEUTIC CLASS

Drugs for miotics and glaucoma

STORAGE CONDITIONS

Store in a cool, dry place and protected from light. Keep out of reach of children. Discard the container 4 weeks after opening.